Abstract

In general, chest radiographs (CXR) have high sensitivity and moderate specificity for active pulmonary tuberculosis (PTB) screening when interpreted by human readers. However, they are challenging to scale due to hardware costs and the dearth of professionals available to interpret CXR in low-resource, high PTB burden settings. Recently, several computer-aided detection (CAD) programs have been developed to facilitate automated CXR interpretation. We conducted a retrospective case-control study to assess the diagnostic accuracy of a CAD software (qXR, Qure.ai, Mumbai, India) using microbiologically-confirmed PTB as the reference standard. To assess overall accuracy of qXR, receiver operating characteristic (ROC) analysis was used to determine the area under the curve (AUC), along with 95% confidence intervals (CI). Kappa coefficients, and associated 95% CI, were used to investigate inter-rater reliability of the radiologists for detection of specific chest abnormalities. In total, 317 cases and 612 controls were included in the analysis. The AUC for qXR for the detection of microbiologically-confirmed PTB was 0.81 (95% CI: 0.78, 0.84). Using the threshold that maximized sensitivity and specificity of qXR simultaneously, the software achieved a sensitivity and specificity of 71% (95% CI: 66%, 76%) and 80% (95% CI: 77%, 83%), respectively. The sensitivity and specificity of radiologists for the detection of microbiologically-confirmed PTB was 56% (95% CI: 50%, 62%) and 80% (95% CI: 77%, 83%), respectively. For detection of key PTB-related abnormalities ‘pleural effusion’ and ‘cavity’, qXR achieved an AUC of 0.94 (95% CI: 0.92, 0.96) and 0.84 (95% CI: 0.82, 0.87), respectively. For the other abnormalities, the AUC ranged from 0.75 (95% CI: 0.70, 0.80) to 0.94 (95% CI: 0.91, 0.96). The controls had a high prevalence of other lung diseases which can cause radiological manifestations similar to PTB (e.g., 26% had pneumonia, 15% had lung malignancy, etc.). In a tertiary hospital in India, qXR demonstrated moderate sensitivity and specificity for the detection of PTB. There is likely a larger role for CAD software as a triage test for PTB at the primary care level in settings where access to radiologists in limited. Larger prospective studies that can better assess heterogeneity in important subgroups are needed.

Highlights

  • Tuberculosis (TB) is the world’s leading infectious disease killer

  • Six controls were reclassified as cases after determining that they had microbiologically-confirmed pulmonary TB (PTB) diagnosed at another hospital

  • After reviewing electronic laboratory records, radiological records and discharge summaries, 149 (20%) patients were excluded from the analysis for the following reasons: positive by Xpert MTB/RIF or culture at some point during 2017 according to electronic laboratory record (n = 31), smear positive (n = 11), wrong specimen type (n = 3), no smear result/no electronic record (n = 9), no CXR (n = 15), CXR unreadable (n = 21), discharge summaries were not available for review (n = 2) and empirically initiated on anti-TB therapy (n = 51)

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Summary

Introduction

Tuberculosis (TB) is the world’s leading infectious disease killer. Early and accurate detection of TB is essential to achieve global control of the disease. India has the world’s largest TB burden and accounts for over one quarter of the 3.8 million ‘missing cases’ which go undiagnosed each year[1]. This gap is largely due to the lack of accurate, rapid and cost-effective tools for TB screening and diagnosis[2]. With the advent of digital CXR, there is renewed interest in using CXR interpreted by computer-aided detection (CAD) software programs for PTB detection[3]. These programs have the potential to overcome many of the barriers to CXR-based screening and triage by standardizing and automating CXR interpretation. We assessed the software’s performance for detection of PTB using microbiological confirmation as a reference standard and the software’s performance for detection of specific chest abnormalities (e.g., cavities) using radiologist’s readings as a reference standard

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